On July 10, 2023 Infinity Pharmaceuticals, Inc. (Nasdaq: INFI) ("Infinity"), a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming drug candidate, reported further design features of its Phase 2 MARIO-8 study in SCCHN (Press release, Infinity Pharmaceuticals, JUL 10, 2023, View Source [SID1234633127]).

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The adaptive design of the MARIO-8 study is intended to optimize the dose of the oral drug candidate, eganelisib, in combination with the standard dose of pembrolizumab, in 40-70 patients in Part A of the study. The dose optimization phase of the study will evaluate two dose regimens of eganelisib; a 30mg regimen, dosed daily for two out of every three weeks, and a 20mg regimen, with continuous daily dosing. The company has received FDA feedback and, pending final FDA review and subject to the successful close of the company’s proposed merger with MEI Pharma, Inc. ("MEI"), preliminary safety and efficacy data to inform the dose selection are expected in the second half of 2024.

The selected eganelisib dose, in combination with pembrolizumab, will be further evaluated in Part B of the study in approximately 100 additional patients, with the primary endpoint of overall survival and secondary endpoints of progression free survival and safety.

"Our ability to optimize the eganelisib dose in MARIO-8 is a very attractive component of this study, furthering our objective of bringing eganelisib to patients with squamous cell cancer of the head and neck. These patients are in urgent need of better therapies and the data generated to date with eganelisib in combination with a checkpoint inhibitor in patients with SCCHN are encouraging," said Robert Ilaria, MD, Infinity’s Chief Medical Officer. "We are pleased to have received the FDA’s feedback and to have made great progress toward study initiation."

To view presentations on eganelisib, the treatment landscape in SCCHN, the data generated to date with eganelisib in patients with SCCHN from the MARIO-1 study, and the MARIO-8 study design by Infinity Chief Medical Officer Robert Ilaria and Dr. Ezra Cohen, the principal SCCHN investigator in the MARIO-1 study, please view the webcast on Infinity’s website which can be located at www.infi.com under the Investor/Media tab in the Events and Presentations folder titled "MEI Pharma and Infinity Merger and Clinical Program Update June 19, 2023".

Update on Proposed Transformative Merger with MEI

Infinity is pleased to report that a second leading independent proxy advisory firm, Glass, Lewis & Co ("Glass Lewis") has joined Institutional Shareholder Services Inc. ("ISS") in recommending that stockholders of Infinity and MEI vote FOR the merger between the two companies. The combined company is expected to have an attractive combined clinical pipeline, strong balance sheet, and multiple potential value creation opportunities for stockholders.

Infinity stockholders are reminded to vote their proxies today FOR the proposals described in the joint proxy statement and prospectus, prior to the Infinity virtual special meeting of stockholders on July 14, 2023, at 10 a.m. Eastern Time.

It is very important that Infinity stockholders vote, as not voting has the same effect as voting against the proposed merger.

Infinity Stockholders who have questions about voting their proxy are encouraged to contact Morrow Sodali LLC who are assisting us, at 1-800-662-5200 or [email protected].